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mifepristone (Mifeprex)

What is the most important information I should know about Mifeprex?

This medication guide provides information about the Mifeprex brand of mifepristone. Korlym is another brand of mifepristone that is not covered in this medication guide.

Mifeprex is used to end an early pregnancy that is not further along than 49 days (7 weeks) after the first day of your last menstrual period. MIFEPREX MUST NOT BE USED IN AN ATTEMPT TO END PREGNANCY BEYOND 7 WEEKS.

Do not use Mifeprex if you do not intend to end your pregnancy. Mifeprex can cause birth defects in an unborn baby if the treatment procedure does not fully terminate the pregnancy. If you are still pregnant after 2 weeks, you may need surgery to end the pregnancy completely.

You should not take Mifeprex if you are allergic to prostaglandins or medicines that contain misoprostol (Cytotec or Arthrotec). Do not take Mifeprex if you have a bleeding or blood clotting disorder, problems with your adrenal glands, an ectopic pregnancy, porphyria, if you take a blood thinner or certain steroid medications, or if you have an intrauterine device (IUD) in place.

Before receiving this medication, you must read a Mifeprex Medication Guide. Then you must sign a Patient Agreement form stating that you understand the risks and benefits of using this medication. Tell your doctor if you have heart disease, high blood pressure, liver or kidney disease, a breathing disorder, diabetes, anemia, or if you smoke.

Treatment with Mifeprex requires 3 visits to your doctor. Do not use this medication if you cannot attend all required follow-up visits.

Mifeprex causes cramping and bleeding, which are signs that medication is working properly. But sometimes you can have cramping and bleeding and still be pregnant. Only your doctor can confirm whether your pregnancy has been completely terminated. Do not miss any follow-up visits.

Call your doctor or seek emergency medical help if you still have any of the following symptoms more than 24 hours after taking Mifeprex: ongoing fever, severe stomach pain, heavy vaginal bleeding, nausea, vomiting, diarrhea, or if you feel like you might pass out.

It is possible to get pregnant again right after terminating a pregnancy with Mifeprex. You may begin using birth control after your doctor has confirmed that treatment with Mifeprex has effectively ended your pregnancy.

What is mifepristone (Mifeprex)?

Mifeprex blocks the actions of a hormone needed to maintain a pregnancy.

Mifeprex is used to end an early pregnancy (no further along than 7 weeks, or 49 days after the first day of your last menstrual period). Mifeprex is sometimes used together with another medicine called misoprostol (Cytotec).

This medication guide provides information about the Mifeprex brand of mifepristone. Korlym is another brand of mifepristone that is not covered in this medication guide.

Mifeprex may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking Mifeprex?

Mifeprex is used to end an early pregnancy that is not further along than 49 days (7 weeks) after the first day of your last menstrual period. MIFEPREX MUST NOT BE USED IN AN ATTEMPT TO END PREGNANCY BEYOND 7 WEEKS.

Treatment with Mifeprex requires 3 visits to your doctor. Do not use this medication if you cannot attend all required follow-up visits.

You should not take Mifeprex if you are allergic to prostaglandins or medicines that contain misoprostol (Cytotec or Arthrotec), or if you have:

an intrauterine device, or IUD (it must be removed before you take Mifeprex);

if you take certain steroid medications or a blood thinner such as warfarin (Coumadin, Jantoven);

if it has been more than 49 days (7 weeks) since your last menstrual period began;

if you cannot return for the next 2 visits to your doctor; or

if you cannot easily get emergency medical help if needed in the 2 weeks after you take Mifeprex.

To make sure you can safely take Mifeprex, tell your doctor if you have any of these other conditions:

heart disease, high blood pressure;

liver or kidney disease;

asthma, bronchitis, or other breathing problems;

diabetes (if you use insulin);

severe anemia (lack of red blood cells); or

if you smoke 10 or more cigarettes per day.

FDA pregnancy category X. Do not use Mifeprex if you do not intend to end your pregnancy. Mifeprex can cause birth defects in an unborn baby if the treatment procedure does not fully terminate the pregnancy. If you are still pregnant after 2 weeks, you may need surgery to end the pregnancy completely.

It is not known whether Mifeprex passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is Mifeprex given?

Before receiving this medication, you must read a Mifeprex Medication Guide. Then you must sign a Patient Agreement form stating that you understand the risks and benefits of using this medication.

Treatment with Mifeprex requires 3 visits to your doctor.

At the first visit (Day 1) you will be take 3 Mifeprex tablets at one time.

Two (2) days later at the second visit (Day 3), your doctor will check your uterus to determine if the pregnancy has ended.

If you are still pregnant on Day 3, you will take 2 misoprostol tablets at one time. Misoprostol can cause cramps, nausea, diarrhea, and other side effects. Your doctor may give you medication to treat or prevent these side effects.

Two (2) weeks later at the third visit (Day 14 after you took Mifeprex), your doctor will again check your uterus to make sure the pregnancy has completely ended.

Treatment with Mifeprex causes cramping and bleeding, which are signs that medication is working properly. But sometimes you can have cramping and bleeding and still be pregnant. Only your doctor can confirm whether your pregnancy has completely ended. Using a home pregnancy test kit is not effective in confirming that your uterus has been completely cleared of the pregnancy. Do not miss your follow-up visits on Day 3 and Day 14.

Call your doctor or seek emergency medical help if you still have any of the following symptoms more than 24 hours after taking Mifeprex: ongoing fever, severe stomach pain, heavy vaginal bleeding, nausea, vomiting, diarrhea, or if you feel like you might pass out.

In an emergency situation, make sure any doctor caring for you knows that you have taken Mifeprex.

If you are still pregnant after 2 weeks, you may need surgery to end the pregnancy completely. Carrying the pregnancy to term after taking Mifeprex may result in birth defects in the baby. Talk with your doctor about your treatment options.

You may continue bleeding for up to 30 days after taking Mifeprex. Bleeding may be heavier than a normal heavy period, and you may also pass blood clots and tissue.

It is possible to get pregnant again right after terminating a pregnancy with Mifeprex. You may begin using birth control after your doctor has confirmed that treatment with Mifeprex has effectively ended your pregnancy.

What happens if I miss a dose?

Since Mifeprex is used as a single dose, it does not have a daily dosing schedule. Call your doctor for instructions if you miss any follow-up appointment.

What happens if I overdose?

Since Mifeprex is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after taking Mifeprex?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of Mifeprex?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Bleeding and spotting are normal side effects of Mifeprex. Bleeding may be slightly heavier than a normal period. Call your doctor right away if you bleed enough to soak through 2 full-size sanitary pads per hour for 2 hours in a row.

Call your doctor at once if you have any other serious side effect, such as:

general ill feeling and fast heart rate;

a fever higher than 100.4 degrees F (38 degrees C);

severe pelvic pain or tenderness;

severe or ongoing nausea, vomiting, diarrhea, weakness; or

no vaginal bleeding at all after taking Mifeprex.

Less serious side effects may include:

mild pelvic pain or cramps;

mild nausea or diarrhea, mild stomach pain;

dizziness, tired feeling; or

back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Mifeprex?

Tell your doctor about all other medicines you use, especially:

medication to treat hepatitis or HIV;

medicine to prevent rejection of a transplanted organ;

migraine headache medication;

an antibiotic or antifungal medication;

heart or blood pressure medication;

seizure medication; or

thyroid medication.

This list is not complete and other drugs may interact with Mifeprex. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about Mifeprex.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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